Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04733716 |
| Other study ID # |
2020/13 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2019 |
| Est. completion date |
January 1, 2021 |
Study information
| Verified date |
January 2021 |
| Source |
Umraniye Education and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Total knee arthroplasty (TKA) is an effective surgical procedure for reducing knee joint pain
and improving the quality of life of patients with advanced knee osteoarthritis. Although
advanced surgical techniques and prosthesis design are achieved, postoperative pain is a
significant factor that affects those patients who have undergone TKA with a satisfactory
outcome. The reasons for postoperative pain after TKA are somewhat unclear Although there are
studies evaluating the preoperative and postoperative conditions of the patients using pain
scores, these values differ greatly in patients who are suitable for the same procedure.
Previous studies have demonstrated that variability exists between individuals in basal pain
sensitivity, which is assessed using quantitative sensory testing To our knowledge, only one
study has investigated the pain condition using an algometer and postoperative pain and the
analgesic requirement on the day of surgery and during the postoperative period.Unlike the
above-cited study, in this study, we evaluated the effect of using a tourniquet on
early-stage pain and 1-year postoperative functional outcomes when patients were divided into
two groups according to the pain threshold.
Description:
This is a prospective double-blinded, randomized controlled trial diagnostic study conducted
at a single center from June 2018 to December 2019. Patients who underwent total knee
arthroplasty due to end-stage knee osteoarthritis were asked to volunteer to participate in
this study. A prospective randomized study was conducted using a digital algometer to assess
the pain sensitivity for the relationship between postoperative early-stage pain score and
first-year functional scores in patients with or without using tourniquet who underwent
primary TKA. Patients were randomized to with or without tourniquet groups; a random number
generated by the research staff determined the group designation, independent of a senior
surgeon. T All participants in this study gave their written informed consent. Patients with
a neurological disorder, diagnosed with fibromyalgia, history of knee operation, valgus knee,
greater than 30° flexion contracture that had undergone bilateral knee arthroplasty or
revision knee arthroplasty, chronic analgesic users, and those with a psychiatric disease
were excluded from this study.
Preoperative Procedure: All patients had anterior-posterior and lateral radiographs of the
bilateral knees, taken with a standard full-length weight-bearing the patients in bipedal
stance, the knees in maximal extension for anterior-posterior and 30-degree flexion for
lateral radiographs pre and postoperatively. In all patients, range of motion and
contractures of both knee joints were recorded. All patient's educational level was also
assessed. The pain threshold (PT) was evaluated using an analog algometer (Figure 1). The
pain sensitivity was measured on the forearm using two mechanical pain stressors, which
indicate which of an ascending sensory stimulus is first perceived as painful. This device is
a force gauge that is used to apply an increasing amount of force to the skin through a 1 cm2
surface area until the pain threshold is achieved. This algometer stimulates pain, described
as dull pressure at the pain threshold; the reliability and validity of this device have been
reported. The pain sensitivity of all measurement patients was taken on the day before the
surgery by the same author, and these values were blinded from another author who recorded
the repetitive postoperative VAS and knee scores.
Operation Procedure: All patients were operated on in a single-center and experiences in
arthroplasty practice. All the patients were operated on standard spinal anesthesia. All
patients underwent cruciate-retaining Genesis II knee arthroplasty (Smith and Nephew,
Memphis, TN, USA) with a midline incision and medial parapatellar approach with a fixed
bearing design. Patella resurfacing was not performed, while patellar denervation was
performed in all patients. Bone-cement (40 g) was used with a fourth-generation cementing
device.
A pneumatic tourniquet was used before surgery at the proximal thigh and inflated before the
skin incision until skin closure in group 1 and no used in group 2. The tourniquet was
inflated to either 275 or 325 mmHg, depending on the patient's systolic blood pressure.
Peri-operative tranexamic (TXA) acid was administrated intravenously with 20 mg/kg 30 min
before surgery. Periarticular injection was not used for pain control in either group. An
adductor canal block or epidural analgesia was not applied. Intra-articular drainage was used
in every patient, which was removed after 24 h postoperatively.
Postoperative Management and Analgesic Procedure: On the day of surgery, intravenous
paracetamol 1 g was given at 8-h intervals, and intramuscular diclofenac sodium 75 mg and
intravenous tramadol 100 mg in 100 mL normal saline were given at 12-h intervals. This
analgesic procedure was continued at the time of discharge, and all patients were discharged
on the third day of surgery. Physical therapy was started on postoperative day 1 in all
patients. The functional assessments and range-of-motion were measured during routine
physical therapy sessions.
Postoperative Assessment of Pain and Function: VAS score assessment was done at 24 h (rest),
36 h (post-physical therapy), and 48 h (rest) postoperatively. The Knee Society Clinical
Scoring System (KSS) was also used for evaluation of functional outcomes, which is a
condition-specific validated questionnaire widely used to evaluate the functional
capabilities of the knee joint before and after total knee arthroplasty. The KSS was done in
the first year postoperatively. The KSS consists of two parts. One part is the knee score
(KSS1), which includes pain (maximum 50 points), stability, total range of flexion, and other
items (varus, valgus, extension delay, and flexion contracture). The other part (KSS2) is the
function score, which has two components, walking capacity and stair-climbing ability and
deductions done if the patient using any assistive devices.
